PUFFINS Brain Health Study (PUFFINS BH)

May 4, 2026 updated by: University of Aberdeen

Proving the Utility of Ultra-low Field MRI for Assessing Brain Health

Small vessel disease (SVD) is a major cause of stroke and contributor to dementia cases. As work continues to develop new treatments to address the impact of SVD, new imaging techniques are needed to identify and track the progression of brain changes that occur with SVD. Magnetic Resonance Imaging (MRI) is the gold standard to diagnose poor brain health due to small vessel disease. However, current MRI systems are expensive and complex to operate, and so access is limited.

Low-field MRI technology, operating at magnetic field strengths many times lower than conventional MRI, can make brain imaging much more cost-effective and accessible. However, further work is needed to develop low-field MRI towards clinically feasible assessments of brain health. The University of Aberdeen hosts a unique network of researchers and imaging technologies that is now making it possible to test and develop different low-field MRI approaches towards solving key healthcare challenges.

The aim of this study is to evaluate the potential of two distinct approaches, field-cycling imaging (FCI) and ultra-low field MRI (ULF-MRI), to detect brain changes linked with small vessel disease. Automated methods will be developed to analyse images and extract measurements that detect and track progression of disease severity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cerebral small vessel disease (SVD) is a major underlying contributor to ischaemic and haemorrhagic stroke, cognitive decline, and dementia. Neuroimaging features of SVD have been shown to be associated with increased risk of stroke occurrence, reoccurrence, and cognitive decline post-stroke. New approaches are needed that target SVD diagnosis, monitoring, and treatment, to improve outcomes across the stroke and cognitive decline care pathways. However, providing equitable access to advanced medical technologies across the Scottish population is becoming a significant burden on the NHS and wider clinical community. Low-field MRI, which is both more cost-effective and less complex to operate, has the potential to address this growing societal burden at a whole-population level. Whilst on-going research efforts remain focussed on developing new interventions to slow progression of SVD and improve treatment outcomes, work is also needed to improve approaches to assess SVD pathophysiology, severity, progression, and treatment outcome. Repeated assessment with magnetic resonance imaging (MRI), is recognised as the best solution to detect the multiple features that combine to produce SVD. This has the potential to identify markers of stroke risk and cognitive decline and, in future, guide tailored treatments to better manage stroke risk and improve post-stroke long-term outcomes. No other imaging technique, blood test or other assessment can provide the necessary information. However, the high cost and infrastructure demands of conventional MRI means that while it is feasible for clinical trials and research, it cannot realistically be used for widespread repeated brain imaging assessment, or screening, for SVD. For this reason, robust and reliable imaging methods that can be easily implemented across the whole Scottish population, rural/urban, wealthy/deprived must be developed. Operating at magnetic field strengths up to 10,000 times lower than conventional MRI, low-field MRI technologies provide a unique opportunity to make repeated brain imaging cost-effective and accessible in community and outpatient settings. The utility of commercially available portable low-field MRI technology, operating at a fixed field of 64 mT (milliTesla), has already been proven for imaging acute stroke at the bedside of patients and recent preliminary findings have indicated its feasibility to detect moderate and severe SVD. However, the novelty of portable low-field MRI means that its full potential has yet to be realised, and work is now required to develop low-field quantitative imaging approaches to enhance the capabilities of low-field MRI to extract underlying features related to brain health and SVD severity. We aim to provide a stepping-stone to optimised fixed low-field MRI technology by leveraging the unique capabilities of field-cycling imaging (FCI), a unique whole-body MRI technology developed at the University of Aberdeen. IRAS Form Reference: 25/PR/0216 IRAS Version 6.4.1 Date: 13/02/2025 350553/1711955/37/104 7Investigations using field-cycling technologies, which vary the strength of the magnetic field during acquisition, have shown unique sensitivity to tissue features and contrast mechanisms that are invisible at higher, fixed, magnetic fields such as 1.5 and 3T. Furthermore, using FCI, differences between healthy tissue and stroke pathology have been observed. Our own preliminary results, using the mark 2 FCI scanner to image patients with SVD at field strengths between 0.2 and 200 mT have shown a significant positive linear correlation between the volume of SVD extracted from FCI images and from 3T MRI images. However, these preliminary results, limited to a single slice acquisition at 3.1 x 3.1 x 10 mm resolution, do not provide the full evidence needed to design new, cost-effective and accessible, lowfield MRI scanners that would enable widespread, repeated brain imaging assessment for SVD. The objective of this proposal is therefore to address this evidence gap and to inform the design of new low-field MRI technologies tailored to extracting key markers of SVD. First, by utilising the unique capabilities of the new mark 3 FCI scanner, now onsite at Aberdeen Royal Infirmary, imaging data will be acquired at multiple different field strengths, and a higher pixel resolution. This data will be used to determine the most effective low-field approach to identify markers of SVD (e.g., white matter changes, reduced perfusion, microbleeds, recent lacunar infarcts) and SVD progression. Second, by acquiring imaging data from both field-cycling imaging (FCI) and a separate fixed low-field MRI scanner, the extent of agreement between assessments of SVD will be examined.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB24 3FX
        • Recruiting
        • Aberdeen Biomedical Imaging Centre, University of Aberdeen
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gordon D Waiter
        • Sub-Investigator:
          • Adamu Ali-Gombe, PhD
        • Sub-Investigator:
          • Nicholas Senn, PhD
        • Principal Investigator:
          • Mary Joan MacLeod, PhD
      • Aberdeen, United Kingdom, AB24 3FX
        • Recruiting
        • AMT Center, Univeristy of Aberdeen
        • Sub-Investigator:
          • Nicholas Senn, PhD
        • Principal Investigator:
          • Mary Joan MacLeod, PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mathieu Sarracanie, PhD
        • Sub-Investigator:
          • Najat Salameh, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who small vessel disease, Fazekas score 1 to 3. Study population will be recruited from the NHS Grampian region.

Description

Inclusion Criteria:

  • Adults ≥ 50 years old.
  • Subjects who do not report problems with memory.
  • Small vessel disease (Fazekas score 1 to 3).
  • Suitable body habitus.
  • Able to understand written and spoken English.

Exclusion Criteria:

  • History of major stroke (minor stroke/Transient Ischaemic Attacks or lacunar stroke are acceptable).
  • Individuals unable to give informed consent.
  • Contra-indications to MRI scanning such as implantable cardiac devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with mild small vessel disease (Fazekas score = 1)
Participants with mild small vessel disease, defined by a Fazekas score of 1.
Other: Enrolment 3T MRI research scan
Enrolment research scan performed with 3T magnetic resonance imaging scanner.
Other: Enrolment Field-cycling Imaging research scan
Enrolment research scan performed with Field-Cycling Imaging scanner.
Other: Enrolment cognitive assessment interview
Enrolment interview performed to complete cognitive assessment scoring of Montreal Cognitive Assessment, EQ-5D, Trail making test, Animal naming test, controlled oral word association test, and Hopkins Verbal Learning Test.
Participants with moderate small vessel disease (Fazekas score = 2)
Participants with mild small vessel disease, defined by a Fazekas score of 2.
Other: Enrolment 3T MRI research scan
Enrolment research scan performed with 3T magnetic resonance imaging scanner.
Other: Enrolment Field-cycling Imaging research scan
Enrolment research scan performed with Field-Cycling Imaging scanner.
Other: Enrolment cognitive assessment interview
Enrolment interview performed to complete cognitive assessment scoring of Montreal Cognitive Assessment, EQ-5D, Trail making test, Animal naming test, controlled oral word association test, and Hopkins Verbal Learning Test.
Participants with severe small vessel disease (Fazekas score = 3)
Participants with mild small vessel disease, defined by a Fazekas score of 3.
Other: Enrolment 3T MRI research scan
Enrolment research scan performed with 3T magnetic resonance imaging scanner.
Other: Enrolment Field-cycling Imaging research scan
Enrolment research scan performed with Field-Cycling Imaging scanner.
Other: Enrolment cognitive assessment interview
Enrolment interview performed to complete cognitive assessment scoring of Montreal Cognitive Assessment, EQ-5D, Trail making test, Animal naming test, controlled oral word association test, and Hopkins Verbal Learning Test.
Follow up group. Participants with moderate or severe small vessel disease (Fazekas score = 2 or 3).
Participants with moderate or severe SVD (deep white matter Fazekas 2 or 3) who will undergo an extra low-field MRI scan and will have a follow up visit at 18 months.
Other: Enrolment 3T MRI research scan
Enrolment research scan performed with 3T magnetic resonance imaging scanner.
Other: Enrolment Field-cycling Imaging research scan
Enrolment research scan performed with Field-Cycling Imaging scanner.
Other: Enrolment cognitive assessment interview
Enrolment interview performed to complete cognitive assessment scoring of Montreal Cognitive Assessment, EQ-5D, Trail making test, Animal naming test, controlled oral word association test, and Hopkins Verbal Learning Test.
Other: Enrolment ultra-low field MRI research scan
Enrolment research scan performed with ultra-low field MRI scanner
Other: Follow up 3T MRI research scan
Follow up research scan performed with 3T magnetic resonance imaging scanner, 18-months after baseline scans.
Other: Follow up Field-cycling Imaging research scan
Follow up research scan performed with Field-Cycling Imaging scanner, 18-months after baseline scans.
Other: Follow up ultra-low field MRI research scan
Follow up research scan performed with Ultra-low field MRI scanner, 18-months after baseline scans.
Other: Follow up cognitive assessment interview
Follow up interview performed to complete cognitive assessment scoring of Montreal Cognitive Assessment, EQ-5D, Trail making test, Animal naming test, controlled oral word association test, and Hopkins Verbal Learning Test. Performed 18-months after baseline interview.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Small vessel disease volume agreement between enrolment Field-Cycling Imaging and enrolment 3T MRI.
Time Frame: At enrolment

Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and 3T MRI.

Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and 3T MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.
At enrolment
Small vessel disease volume agreement between follow up Field-Cycling Imaging and follow up 3T MRI.
Time Frame: At 18 month follow up

Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and 3T MRI.

Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and 3T MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.
At 18 month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Small vessel disease volume agreement between enrolment Field-Cycling Imaging and enrolment Ultra-low Field MRI.
Time Frame: At enrolment

Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and Ultra-low Field MRI.

Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and Ultra-low Field MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.
At enrolment
Small vessel disease volume agreement between follow up Field-Cycling Imaging and follow up Ultra-low Field MRI.
Time Frame: At 18 month follow up

Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and Ultra-low Field MRI.

Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and Ultra-low Field MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.
At 18 month follow up
Strength of association between small vessel disease volume obtained from Field-Cycling Imaging, with small vessel disease severity (Fazekas score), age, mood, and cognition.
Time Frame: At enrolment
Linear regression analysis will be performed to assess the strength of associations between small vessel disease volume obtained from Field-Cycling Imaging and small vessel disease severity (Fazekas score), age, mood and cognition derived from the memory, language, and processing speed measures.
At enrolment
Strength of association between small vessel disease volume obtained from Ultra-low Field MRI, with small vessel disease severity (Fazekas score), age, mood, and cognition.
Time Frame: At 18 month follow up
Linear regression analysis will be performed to assess the strength of associations between small vessel disease volume obtained from ultra-low field MRI and small vessel disease severity (Fazekas score), age, mood and cognition derived from the memory, language, and processing speed measures.
At 18 month follow up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Extent of linear associations between relaxation rate measurements and multiparametric 3T MRI.
Time Frame: At enrolment
General linear model analysis of relaxation rate measurements, apparent diffusion coefficient and transverse relaxation time, magnetitic transfer ratio, chemical exchange saturation transfer tissue pH, will be performed to investigate the linearity of associations. Exploratory factor analysis will be used to reduce number of 3T MRI parameters to hypothesised factors of microstructure integrity, iron concentration, degree of demyelination and tissue pH.
At enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aberdeen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NHS Grampian

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mary Joan MacLeod, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2-079-24
  • 25/YH/0053 (Other Identifier: National Health Service Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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